Transobturator surgical articles and methods

ABSTRACT

A surgical instrument for treating incontinence includes a handle portion elongate along a handle axis and a needle portion connected to the handle portion. The needle portion has a spacer portion along the handle axis, and has a distal end. The needle portion includes a substantially helical portion that is a variable spiral portion, extending from the straight spacer portion. The variable spiral portion is sized and shaped to extend from an incision substantially adjacent the patient&#39;s obturator foramen through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus. The needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 10/306,179, filed Nov. 27, 2002, now U.S. Pat. No. 7,070,556which claims the benefit of U.S. Provisional Applications Ser. Nos.60/362,806, filed Mar. 7, 2002; 60/380,797, filed May 14, 2002;60/402,007, filed Aug. 8, 2002; and 60/414,865 filed Sep. 30, 2002, allof which are herein incorporated by reference.

BACKGROUND

Urinary incontinence is a significant health concern worldwide. In theurology field, needles, suture passers and ligature carriers areutilized in a variety of procedures, many of which are designed to treatincontinence. Examples of such surgical instruments included Stameyneedles, Raz needles, and Pereyra needles. See Stamey, EndoscopicSuspension of the Vesical Neck for Urinary Incontinence in Females, Ann.Surgery, pp. 465-471, October 1980; and Pereyra, A Simplified SurgicalProcedure for the Correction of Stress Incontinence in Women, West. J.Surg., Obstetrics & Gynecology, pp. 243-246, July-August 1959.

A pubovaginal sling procedure is a surgical method involving theplacement of a sling to stabilize or support the bladder neck orurethra. There are a variety of different sling procedures. Descriptionsof different sling procedures are disclosed in U.S. Pat. Nos. 5,112,344;5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686; 6,042,534 and6,110,101.

Some pubovaginal sling procedures extend a sling from the rectus fasciain the abdominal region, to a position below the urethra, and back againto the rectus fascia. Although serious complications associated withsling procedures are infrequent, they do occur. Complications includeurethral obstruction, prolonged urinary retention, bladder perforations,damage to surrounding tissue, and sling erosion.

The Tension-free Vaginal Tape (TVT) procedure (available from Ethicon,of NJ.) utilizes a Prolene™ nonabsorbable, polypropylene mesh. Problemswith the TVT procedure are documented in the literature and patents.Problems associated with the TVT procedures and the like areacknowledged and described in PCT publication nos. PCT WO 00/74613 andPCT WO 00/74594, U.S. Pat. Nos. 6,273,852; 6,406,423; and 6,478,727, andpublished U.S. Pat. Application Nos. 2002'0091373A1, 2002/0107430A1,2002/0099258A1 and 2002/0099259A1. A cadaver study indicated that theTVT needle is placed in close proximity to sensitive tissue such assuperficial epigastric vessels, inferior epigastric vessels, theexternal iliac vessel and the obturator. See, Walters, Mark D.,Percutaneous Suburethral Slings: State of the Art, presented at theconference of the American Urogynecologic Society, Chicago (October2001) and PCT International Publication No. WO 02/26108.

Additional sling procedures are disclosed in Published U.S. Pat. Appl.No. US 2001/0018549A1, and PCT Publication Nos. WO 02/39890 and WO02/069781.

A significant percentage of pubovaginal sling procedures are conductedafter previous pelvic surgery. A pubovaginal sling procedure can beparticularly challenging if the patient has scarring as a result ofprevious pelvic surgeries or other anatomical problems. The additionalcomplications presented by significant scarring present surgeons with agreater surgical challenge and may lead some surgeons to forego anotherwise beneficial sling procedure. Unfortunately, this reduces apatient's options for treating incontinence.

Published U.S. Pat. Appl. No. 2002/0099260 discloses an implantabledevice or tape for use in correcting urinary incontinence. The tapeincludes sprayed polypropylene fibers that result in a strongimplantable device. The tape also has a silicone-coated portion andtapered nee ends. The procedure utilizes an Emmet needle that includesan eyelet. To create the eyelet, the distal portion of the Emmet needleis enlarged. A surgical procedure using an Emmet needle is believed tobe described in the French publication D. Dargent, S. Bretones, P.George, and G. MeHier, Pose d'un ruban sous uretral oblique par voieobturatrice dans le traitement de l'incontinence urinaire feminine,Gynecol. Obstet. Fertil. 2002; 30: 576-582.

In the procedure described in U.S. Pat. Appl. No. 2002/0099260, anincision is made in the perineal skin facing the obturator and in thegroin. The Emmet needle is first inserted through the cutaneousincision. The Emmet needle is first introduced perpendicular to theperineum for about 15 mm (passing through the internal obturator muscleas far as just outside the ischiopubic branch). The Emmet needle is thenallowed to describe its curvature. The free end of the tape is thenslipped into the eyelet of the needle. The needle/tape connection isthus reversible as one merely needs to unthread the tape from the eyeletto separate the tape from the needle. Separation of the tape and needlewhile both are within the body is undesirable as it would require theneedle to be repassed through the body.

The needle with the tape extending through the eyelet is then pulledback though the skin incision. The eyelet and threaded tape present asudden discontinuity encountered by the tissue that can make tape andneedle passage inconvenient and unnecessarily irritative or traumatic totissue. Additionally, the final placement of the sling may not beoptimum in this procedure.

SUMMARY OF THE INVENTION

In one aspect, the present invention includes a handle portion elongatealong a handle axis and a needle portion connected to the handleportion. The needle portion has a substantially straight spacer portionalong the handle axis, and has a distal end. The needle portion includesa substantially helical portion that is a variable spiral portion,extending from the straight spacer portion. The variable spiral portionis sized and shaped to extend from an incision substantially adjacentthe patient's obturator foramen through the obturator foramen along apath in a region between the superior pubic ramus and the inferior pubicramus. The needle portion has a structure near the distal end thatassociates the instrument with an implantable material configured totreat incontinence.

In another embodiment, the invention includes a surgical instrument fortreating incontinence. The instrument includes a handle portionelongated along a handle axis, a needle portion having a substantiallystraight spacer portion along the handle axis, a substantial structurein three dimensions and a distal end. The needle portion has asubstantially helical portion that is a variable spiral portionextending from the spacer portion and is sized and shaped to extend froman incision substantially adjacent the patient's obturator foramenthrough the obturator foramen along a path in a region between thesuperior pubic ramus and the inferior pubic ramus such that the needlecan be associated with an implantable material for treating theincontinence. The variable spiral portion has a tissue clearance depthof greater than about 1.5 inches and less than about 2.5 inches. Theneedle portion includes structure near the distal end for associatingthe instrument with the implantable material for treating theincontinence. comprises a novel surgical instrument for treatingincontinence. The instrument comprises a handle portion, and a needleportion with a distal end. Unlike the Emmet needle of the prior art, thenovel instrument has substantial structure in three dimensions. Theneedle portion is sized and shaped to extend between an incisionsubstantially adjacent the patient's obturator foramen and a vaginalincision. The needle portion also has structure near the distal end forassociating the instrument with an implantable material for treating theincontinence. Preferably, the needle portion includes a portion that issubstantially helically shaped, more preferably, it is a variable helixshape. The structure for associating the instrument with an implantablematerial can comprise an eyelet or a dilator or other structure.

The handle portion is preferably elongate along a handle axis, theneedle portion includes a substantially straight spacer portion alongthe handle axis, and a variable spiral portion extending from the spacerportion. The variable spiral portion preferably has a tissue clearancedepth of greater than about 1.5 inches and less than about 2.5 inches,and a maximum width of greater than about 1.25 inches and less thanabout 3 inches.

In one embodiment, the handle portion is elongate defining a mid plane,and the distal end of the novel needle includes a distal tip situatedsubstantially near an extension of the mid plane that is spaced from thehandle portion.

In another aspect, the present invention comprises a surgical instrumentcomprising first and second ends, the instrument having a portion thatis sized and shaped to extend between a vaginal incision and an incisionsubstantially adjacent the patient's obturator foramen. One of the endshas a handle, at least the other end having securement surfaces for snapfitting the instrument to another surgical component used to treatincontinence. The snap fit preferably provides a substantially permanentattachment between the instrument and the other surgical component.Preferably, the other surgical component comprises a dilator of a slingassembly. The instrument and the dilator preferably have complementaryengagement surfaces for resisting separation of the instrument from thedilator once they are snap fitted together.

In another aspect, the novel instrument comprises a handle portion, aneedle portion having a substantially straight portion projecting fromthe handle portion and a variable spiral portion with a distal end. Thevariable spiral portion is sized and shaped to extend between anincision substantially adjacent the patient's obturator foramen and avaginal incision. The needle portion has structure near the distal endfor associating the instrument with an implantable material for treatingincontinence.

In yet another aspect, the present invention comprises a surgicalassembly for treating incontinence. The assembly includes a surgicalinstrument having a handle portion, a needle portion having substantialstructure in three dimensions and a distal end. The needle portion has aportion that is sized and shaped to extend between an incisionsubstantially adjacent a patient's obturator foramen and a vaginalincision. The assembly may also include an implantable syntheticmaterial and a sheath situated about the implantable synthetic material.In this aspect, the needle portion has structure near the distal end forassociating the instrument with the implantable synthetic material. Theassembly may further including a dilator. Alternatively, needle maycomprise an eyelet.

When the assembly includes a dilator, the dilator preferably hasengagement surfaces for connecting the dilator to the instrument. Thedilator is preferably operatively associated with the sheath andimplantable material. The structure of the needle portion near thedistal end comprises surfaces complementary with the engagement surfacesof the dilator for resisting separation of the instrument from thedilator once they are engaged. Preferably, the needle portion is sizedand shaped for a predetermined side of a patient, and the handle portionincludes indicia indicating the predetermined side of the patient.

In another aspect, the present invention comprises a surgical assemblycomprising a first surgical instrument for use on a right side of apatient. The first surgical instrument comprises a handle portion and aneedle portion having substantial structure in three dimensions and adistal end. The needle portion has a portion that is sized and shaped toextend between an incision substantially adjacent the obturator foramenon the patient's right side and a vaginal incision. The assembly alsohas a second surgical instrument for use on a left side of a patient.The second surgical instrument comprises a handle portion and a needleportion having substantial structure in three dimensions and a distalend. The needle portion of the second instrument has a portion that issized and shaped to extend between an incision substantially adjacentthe obturator foramen on the patient's left side and a vaginal incision.

Preferably, the handle portion of the first surgical instrument includesindicia indicating the first surgical instrument is for use on the rightside of the patient, and the handle portion of the second surgicalinstrument includes indicia indicating the second surgical instrument isfor use on the left side of the patient. The assembly may also includean implantable knitted polypropylene material, and a sheath situatedabout the implantable synthetic material. The first and second surgicalinstruments may include an eyelet for receiving a suture to tie thesurgical instrument to the implantable material. Alternatively, theassembly can have first and second dilators for associating the firstand second surgical instruments with the implantable material.

In another aspect the ‘present invention comprises a surgical instrumentfor treating incontinence comprising a needle sized and shaped to eithera) initially extend through an incision substantially adjacent apatient's obturator foramen and then through a vaginal incision, or b)initially extend through a vaginal incision and subsequently through anincision substantially adjacent a patient's obturator foramen. Notably,such a surgical instrument need not have substantial structure in threedimensions. Preferably, the needle comprises a pair of ends havingsurfaces for affording association with either an implantable slingmaterial or a removable handle. In one embodiment, the needle is sizedand shaped for use on either the patient's right side or left side.

In another aspect, the present invention comprises methods for treatingincontinence. Some methods may utilize substantially three dimensionalneedles, others need not require three dimension needles and othermethods may utilize either three dimensional needles or substantiallyflat needles or both. One method comprises the steps of creating avaginal incision, creating an incision substantially adjacent thepatient's obturator foramen, providing an elongate surgical instrumentcomprising first and second ends, with at least one of the ends havingsecurement surfaces, providing a sling assembly having an implantablesling for treating the incontinence, the sling assembly having surfacescomplementary to the securement surfaces, passing the instrument betweenthe incisions, then snap fitting the instrument to the sling assembly toprovide a substantially permanent attachment between the instrument andthe assembly, then passing the implantable material through tissue fromthe vaginal incision toward the incision substantially adjacent thepatient's obturator foramen.

In another aspect a method comprises the steps of creating a vaginalincision, creating an incision substantially adjacent the patient'sobturator foramen, providing an elongate surgical instrument comprisingfirst and second ends, the instrument having substantial structure inthree dimensions, providing an implant for treating the incontinence,passing the instrument between the incisions, then associating theimplant with the instrument, and passing the implant through tissue andthrough the patient's obturator foramen with the instrument. Preferably,the step of providing an elongate surgical instrument includes the stepof providing an instrument with a portion that is substantiallyhelically shaped, and the step of passing the implant through tissueincludes the step of passing the implant along a substantially threedimensional path. The step of providing an elongate surgical instrumentpreferably includes the step of providing an instrument with an elongatehandle portion having an axis, and the step of passing the instrumentbetween the incisions preferably includes the step of rolling theinstrument about the axis of the handle portion.

In another aspect, the method comprises the steps of creating a vaginalincision, creating an incision substantially adjacent the patient'sobturator foramen, providing an elongate surgical instrument comprisinga handle portion, a needle portion having a substantially straightportion projecting from the handle portion and a variable spiral portionwith a distal end, providing an implant for treating the incontinence,passing at least a portion of the variable spiral portion between theincisions by initially passing the distal end through the incisionsubstantially adjacent the patient's obturator foramen and then throughthe vaginal incision, then associating the implant with a portion of theinstrument that has emerged from the vaginal incision, and then movingthe distal end of the instrument with the implant associated therewithfrom the vaginal incision toward the patient's obturator foramen to passthe implant through tissue. Optionally, the step of associating theimplant with a portion of the instrument that has emerged from thevaginal incision includes the step of using a suture to tie the implantto an eyelet in the distal end of the needle.

In yet another aspect, the method comprises the steps of creating avaginal incision, creating an incision substantially adjacent thepatient's obturator foramen, providing an elongate surgical instrumentcomprising a pair of ends, providing an assembly having an implant fortreating incontinence, initially passing one end of the instrumentinitially through the vaginal incision toward the incision substantiallyadjacent the patient's obturator foramen in a path through the patient'sobturator foramen until one end of the instrument emerges from theincision substantially adjacent the patient's obturator foramen, leavingthe other end of the needle projecting from the vaginal incision, thenassociating the end of the instrument that projects from the vaginalincision with the assembly, and then moving the instrument out of thepatient's body to pass the implant through tissue from the vaginalincision toward the incision substantially adjacent the patient'sobturator foramen to place the implant in a therapeutically effectiveposition.

In another aspect, the present invention comprises the ornamental designfor a surgical instrument, as shown in FIGS. 39 through 45 and describedin the Brief Description of the Drawings. Also, the present inventioncomprises the ornamental design for a surgical instrument, as shown inFIGS. 46 through 52 and described in the Brief Description of theDrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings, in which:

FIG. 1 is a side view of a surgical needle according to one aspect ofthe present invention;

FIG. 2 is a perspective view of a needle, sling and additional optionalelements for use in a kit according to an aspect of the presentinvention;

FIG. 3 is a top view of a kit according to one embodiment of the presentinvention;

FIGS. 4 through 10 are schematic views sequentially showing a surgicalprocedure in accordance with one aspect of the present invention,wherein:

FIG. 4 shows a needle just passing an incision on the right side of apatient's body with the tip of the needle shown in dotted lines;

FIG. 4A is a schematic view of an alternate approach, presented as analternative to the step shown in FIG. 4, showing an inside-out approachusing the needle of FIG. 1, which may be preferred by some surgeon'swhose dominant hand is the right hand, the handle shown being adetachable handle that is movable from one end of the needle to theother, with solid lines being used to show the initial position of thehandle and dashed lines and an arrow used to show a second position ofthe handle;

FIG. 5 illustrates a needle just passing an incision on the left side ofa patient's body with the tip of the needle and part of the surgeon'sfinger shown in dotted lines;

FIG. 6 illustrates one side of a sling assembly and the needle of FIG. 5as it emerges nom the patient's vagina;

FIG. 7 shows the sling system of FIG. 6 after it is attached to theneedle of FIG. 6;

FIG. 8 is a perspective view of a sling assembly being pulled throughthe body by a needle in accordance with the present invention,

FIG. 9 is a schematic view of the approximate relative positions of thepubic bone and the sling after the sling is inserted according to oneaspect of the present invention;

FIG. 10 is an enlarged schematic view showing portions of FIG. 9;

FIG. 11 is a perspective view of another embodiment of the presentinvention;

FIG. 12 is a top view of another embodiment of sling for use inaccordance with the present invention;

FIG. 13A is a front view of an optional handle suitable for use with thepresent invention;

FIG. 13B is a side view of the handle of FIG. 13A;

FIG. 14 is a perspective view of the handle of FIGS. 13A and 13B;

FIG. 15 is a perspective view of a surgical instrument particularlysuitable for use on a right side of a patient's body, according to oneaspect of the present invention;

FIG. 16 is an end view of the needle of FIG. 15;

FIG. 17 is a front view of the needle of FIG. 15;

FIG. 18 is a bottom view of the needle of FIG. 15;

FIG. 15A is a perspective view of a surgical instrument particularlysuitable for use on a right side of a patient's body, which needle issimilar, but not identical to the needle of FIG. 15;

FIG. 16A is an end view of the needle of FIG. 15A;

FIG. 17A is a front view of the needle of FIG. ISA;

FIG. 18A is a bottom view of the needle of FIG. ISA;

FIG. 19 is a perspective view of a surgical instrument particularlysuitable for use on a left side of a patient's body, according to oneaspect of the present invention;

FIG. 20 is an end view of the needle of FIG. 19;

FIG. 21 is a front view of the needle of FIG. 19;

FIG. 22 is a bottom view of the needle of FIG. 19;

FIG. 19A is a perspective view of a surgical instrument particularlysuitable for use on a left side of a patient's body, which needle issimilar, but not identical to the needle of FIG. 19;

FIG. 20A is an end view of the needle of FIG. 19A;

FIG. 20B is an end view of another embodiment of needle according to thepresent invention;

FIG. 21A is a front view of the needle of FIG. 19A;

FIG. 22A is a bottom view of the needle of FIG. 19A;

FIG. 23 is a perspective view of a short dilator for use in accordancewith an aspect of the present invention;

FIG. 24 is an enlarged, sectional view of an internal portion of thedilator of FIG. 23 in accordance with an aspect of the presentinvention;

FIG. 25 is sectional view of the dilator of FIG. 23 in accordance withan aspect of the present invention;

FIG. 25A and 26 are another sectional view of the dilator of FIG. 23illustrating different features;

FIG. 26A is a sectional view illustrating a specially designed distalend portion of a needle inserted into the dilator of FIG. 25;

FIG. 27 is a side view of a distal end portion of a needle according tothe present invention; showing a specially designed shape that iscomplementary to inner surfaces of the dilator of FIG. 23;

FIG. 28 is a perspective view of one embodiment of a sling assemblyaccording to the present invention;

FIG. 29 is a side view of the sling assembly of FIG. 28;

FIG. 30 is a side view of a sling and tensioning suture according to anaspect of the present invention;

FIG. 31 is a schematic illustration of anatomical features, showing apubic bone with dashed lines and incisions;

FIG. 32 is a schematic illustration of the relative positions of thepatient's pubic bone and a novel needle according to the presentinvention, after at least partially inserting the needle;

FIG. 33 is a schematic illustration of the relative positions of thepatient's pubic bone and a novel needle according to the presentinvention, after at least partially inserting the needle;

FIGS. 34 through 38 are perspective views sequentially showing asurgical procedure in accordance with another aspect of the presentinvention, wherein:

FIG. 34 shows a needle just passing an incision on the right side of apatient's body with the tip of the needle shown in dotted lines;

FIG. 35 illustrates a needle just passing an incision on the left sideof a patient's body with the tip of the needle and part of the surgeon'sfinger shown in dotted lines;

FIG. 36 illustrates one side of a sling assembly and the needle of FIG.35 as it emerges from the patient's vagina;

FIG. 37 shows the sling assembly of FIG. 36 after it is attached to theneedle of FIG. 36;

FIG. 38 is a perspective view of a sling assembly being pulled throughthe body by a needle in accordance with the present invention;

FIG. 39 is a perspective view of a design of a surgical instrumentaccording to another aspect of the present invention;

FIG. 40 is a top view of the instrument of FIG. 39;

FIG. 41 is a bottom view of the instrument of FIG. 39;

FIG. 42 is a front view of the instrument of FIG. 39;

FIG. 43 is a rear view of the instrument of FIG. 39;

FIG. 44 is a right end view of the instrument of FIG. 39;

FIG. 45 is a left end view of the instrument of FIG. 39;

FIG. 46 is a perspective view of a design of an instrument according toanother aspect of the present invention;

FIG. 47 is a top view of the instrument of FIG. 46;

FIG. 48 is a bottom view of the instrument of FIG. 46;

FIG. 49 is a front view of the instrument of FIG. 46;

FIG. 50 is a rear view of the instrument of FIG. 46;

FIG. 51 is a right end view of the instrument of FIG. 46;

FIG. 52 is a left end view of the instrument of FIG. 46;

FIG. 53 is a perspective view of a system for use in an inside outprocedure according to the present invention that includes a portionthat is at least partially reusable;

FIG. 54 is a perspective view of a universal system capable of use ininside-out and outside in approaches according to the present invention,which system includes a needle having two ends capable of attachment toeither a handle or a sling assembly;

FIGS. 55-57 sequentially illustrate use of the system of FIG. 54wherein:

FIG. 55 illustrates passage of the needles using inside-out approaches,

FIG. 56 illustrates the needles after the handles have been removed, inpreparation for attachment of a sling assembly on the ends of theneedles previously occupied by the handles;

FIG. 57 illustrates the system during implantation of the sling;

FIG. 58 is a schematic illustration of the system of FIG. 54 used in aninside-out approach (the right side of the patient) and an outside-in(the left side of the patient) approach;

FIGS. 59-61 sequentially illustrate the system of FIG. 54 used inoutside-in approaches wherein:

FIG. 59 illustrates the needles inserted initially through the patient'sskin and thereafter emerging from a vaginal incision;

FIG. 60 illustrates the system just prior to attachment of a slingassembly;

FIG. 61 illustrates the system of FIG. 54 during implantation of thesling;

FIG. 62 is a perspective view of another embodiment of surgical assemblyaccording to the present invention, with a needle suitable for anoutside-in approach (e.g. on the left side of the patient's body) and asling assembly with a needle attached thereto suitable for an inside-outapproach (e.g. through the right side of the patient's body);

FIG. 63 is a perspective view of an alternative embodiment of slingassembly for use in accordance with the present invention;

FIG. 64 is a perspective view of an alternative embodiment of slingassembly for use in accordance with the present invention, whichassembly does not include a sheath;

FIG. 65 is a perspective view of an alternative embodiment of slingassembly for use in accordance with the present invention;

FIG. 66 is a top plan view of an alternative embodiment of slingassembly for use in accordance with the present invention; and

FIG. 67 is a top plan view of an alternative embodiment of slingassembly for use in accordance with the present invention.

The broken line showing of structures on the design of the surgicalinstruments in FIGS. 39 through 52 are for illustrative purposes onlyand form no part of the claimed design.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

The present invention is directed to surgical instruments, assembliesand implantable articles for treating pelvic floor disorders such asincontinence or stress urinary incontinence (SUI) in both men and women.The present invention is also directed to improved surgical proceduresthat utilize the surgical articles.

FIG. 1 is a side view of a sling assembly guide or needle 60 accordingto one aspect of the present invention. The needle 60 is preferablysized and shaped to be suitable for initial insertion through obturatorfascia (see FIGS. 4 through 8). The needle 60 has a length sufficient toextend from the initial incision 400 adjacent the anterior side of thepubic bone, through the obturator foramen 3 (e.g. see FIG. 9) portion ofthe pubic bone to a position on the posterior side of the pubic bone,and to then emerge from a vaginal incision. While FIG. 1 is a side viewor a species of the present invention, the present invention is notlimited to the particular shape disclosed. It is expressly understoodthat a large number of different sizes, shapes and dimensions of needlesare suitable for the present invention.

There are many vulnerable, sensitive pelvic anatomical structures andtissues in the region of the obturator foramen 3, including the pudendalartery (internal), the pudendal canal (Alcock), and nerves (e.g. theperineal and labial). The needle 60 is preferably sized and shaped topass through the obturator foramen 3 along a path that is substantiallyfree of vascular and nerve structures. The size and shape of the needle60 help avoid the sensitive structures. For example, in one embodiment,the path may be in a region between the superior pubic ramus and theinferior pubic ramus (see e.g. FIGS. 4 through 10). The tip of theneedle is preferably substantially blunt to help avoid damage to thesensitive structures. Alternatively, the tip may be slightly sharpenedto assist in the initial passage of the needle.

Preferably, the needle 60 comprises three substantial linear portions60A, 60B and 60C; each situated at an angle relative to the other linearportions. Preferably, the angles are different. The needle 60 preferablyincludes a leading portion 60A, an intermediate portion 60B and atrailing portion 60C.

The leading portion 60A of the needle 60 is sized to extend through theinitial incision 400. The cross-sectional shape of the needle 60 ispreferably substantially circular, but other cross sectional shapes suchas, but not limited to, elliptical, polygonal, square and triangular arealso contemplated herein. The diameter of the leading portion 60A isless than 5 mm, more preferably less than 4 mm, and even more preferablyless than 3.5 mm to avoid damaging or displacing tissue. The suddenangle between the intermediate portion 60B of the needle and the leadingportion 60A helps the surgeon avoid sudden lurches of the needle afterthe end 58 passes through the obturator fascia, as the intermediate 60Bor trailing 60C portions of the needle can be grasped or abut externalportions of the patient to stop an undesirable, sudden lurch throughtissue. The angle also helps the surgeon steer the needle 60 along adesired or predetermined path.

The angle between the intermediate portion 60B and the trailing portion60C is preferable greater than ninety degrees, more preferably, it isgreater than one hundred and twenty degrees. The length of the trailingportion 60C should be sufficient to allow the surgeon to leverage theend 58 of the needle and drive it along its predetermined, desired path.This geometry helps direct the end of the needle 58 back toward thesurgeon. This geometry also helps the surgeon pass the needle throughthis portion of the body and emerge from the vagina without undue tissuetrauma.

FIG. 3 illustrates a kit 15 according to an aspect of the presentinvention. The kit 15 preferably comprises an implantable material (e.g.A sling mesh provided as part of a sling assembly 46), at least one(preferably two) optional handle 64, and at least one (preferably two)needle 60.

The handle 64 is entirely optional. The handle may be removably attachedto the needle, or it may be repositionably attached to the needle.Alternatively, the handle may be permanently attached to the needle 60.FIGS. 13 and 14 illustrate an optional shape of handle 64A suitable forpermanent attachment to the needle 60. Other suitable handles aredisclosed, for example, in U.S. Provisional Patent Application Nos.60/347,494; 60/336,884 and 60/343,658.

The needle 60 is preferably made of a durable, biocompatible surgicalinstrument material such as, but not limited to, stainless steel (e.g.316 stainless steel or 17-4 stainless steel), titanium, Nitinol,polymers, plastics and other materials, including combinations ofmaterials. The needle 60 should have sufficient structural integrity towithstand the various forces (e.g. forces caused by dilator attachment,and penetration/passage of the needle 60 through the various tissues)without undergoing any significant structural deformation. Optionally,the needles 60 could be sufficiently malleable to allow a practitioneror user of the device to modify the needle 60 to a desired shape and,thereby, optimize the procedural approach.

Needles 60 may be disposable or reusable (e.g. sterilizable by steamsterilization procedures). In another aspect of the present invention,the needles 60 may be provided in a kit, such as any of the kitsdescribed in any of published U.S. Pat. Application Nos.2002/0151762-A1; 2002/0147382A1; 2002/0107430A1, 2002/0099258A1 and2002/0099259A1; and U.S. Provisional Application Ser. Nos. 60/263,472,filed Jan. 23, 2001; 60/269,829, filed Feb. 20, 2001; 60/281,350, filedApr. 4, 2001; 60/295,068, filed Jun. 1, 2001; 60/306,915, filed Jul. 20,2001, and U.S. Provisional Patent Application No. 60/332,330, filed Nov.20, 2001.

One embodiment of kit includes the needle 60 and other needles (notshown, but for example including the needles shown in published U.S.Pat. Application No. US-2002-0099258-A1) designed for placing a slingfrom the abdominal rectus fascia, under the urethra, and then back tothe rectus fascia. If a traditional pubovaginal sling procedure seems tobe an option for a patient but, during or prior to the surgicalprocedure, it becomes apparent that excessive scar tissue (e.g. due to aprevious surgery) exists and would render the traditional procedure lessdesirable or impossible, then the needle 60 may be used in analternative approach. Since the needles 60 are also provided in a kit,the surgeon has the option of conducting an alternative surgicalprocedure with the needles 60.

In another aspect of the present invention, a needle may optionallyinclude the capacity to deliver a medicament (e.g. anesthesia) duringthe surgical procedure. For example, the needle 60 may be hollow with anopen end. The needle may have a connector for associating with amedicament reservoir and delivery mechanism (e.g. a syringe).

The present invention may be utilized in conjunction with a wide varietyof sling materials and sling assemblies. The sling may be integral,monolithic, or a composite of different components or segments ofdifferent components. Suitable non-synthetic materials includeallografts, homografts, heterografts, autologous tissues, cadavericfascia, autodermal grafts, dermal collagen grafts, autofascialheterografts, whole skin grafts, porcine dermal collagen, lyophilizedaortic homo grafts, preserved dural homografts, bovine pericardium andfascia lata. Suitable, synthetic materials for a sling includepolymerics, metals and plastics and any combination of such materials.

Commercial examples of non-absorbable materials include Marlex™(polypropylene) available from Bard of Covington, R.I., Prolene™(polypropylene) and Mersilene (polyethylene terphthalate) Hernia Meshavailable from Ethicon, of New Jersey, Gore-Tex™ (expandedpolytetrafluoroethylene) available from W. L. Gore and associates,Phoenix, Ariz., and the polypropylene sling available in the SPARC™sling system, available from American Medical Systems, Inc. OfMinnetonka, Minn. Commercial examples of absorbable materials includeDexon™ (polyglycolic acid) available nom Davis and Geck of Danbury,Conn., and Vicryl™ available from Ethicon. Other examples of suitablematerials include those disclosed in U.S. patent application Ser. No.09/939,098 filed Aug. 24, 2001 and published U.S. Pat. Application No.2002/0072694. More specific examples of synthetic sling materialsinclude, but are not limited to polypropylene, cellulose, polyvinyl,silicone, polytetrafluoroethylene, polygalactin, Silastic, carbon-fiber,polyethylene, nylon, polyester (e.g. dacron) PLLA and PGA. The slingmaterial may be resorbable, absorbable or non-absorbable. Optionally,some portions may be absorbable and other portions may benon-absorbable.

The synthetic slings may be knitted, woven, sprayed or punched from ablank. Some slings may be sufficiently robust to be inserted without aprotective sleeve. In other embodiments, some synthetic slings may havean associated protective sleeve (described in greater detail below) toassist with the implantation.

In one aspect of the invention, the sling may comprise a mesh material.The mesh material comprises one or more woven, knitted or inter-linkedfilaments or fibers that form multiple fiber junctions throughout themesh. The fiber junctions may be formed via weaving, knitting, braiding,bonding, ultrasonic welding or other junction forming techniques,including combinations thereof. In addition, the size of the resultantopenings or pores of the mesh may be sufficient to allow tissuein-growth and fixation within surrounding tissue. As an example, notintended to be limiting, the holes may comprise polygonal shaped holeswith diagonals of 0.132 inches and 0.076 inches.

The quantity and type of fiber junctions, fiber weave, pattern, andmaterial type influence various sling properties or characteristics. Asanother example, not intended to be limiting, the mesh may be wovenpolypropylene monofilament, knitted with a warp tricot. The stitch countmay be 27.5 courses/inch (+ or −2 courses) and 13 wales/inch (+ or −2wales). The thickness of this example is 0.024 inches. This embodimentof sling is preferably associated with a protective sleeve (described ingreater detail below). Non-mesh sling configurations are also includedwithin the scope of the invention.

Referring to FIGS. 29 and 30, the sling mesh 42A is preferably elastic,as opposed to the substantially inelastic mesh available in Europe asUratape® from Porges, and the tape described in Published U.S. Pat.Appl. No. 2002/0099260. As an example, a mesh may be tested to determinewhether it is elastic using a series IX Automated Materials TestingSystem (an Instron), available from Instron Corporation. A 1 cm widesample of the mesh may be placed in the Instron with a crosshead speedset at 5 in/min and a gauge length of 1 inch. An elastic mesh exhibitsat least a 7% elongation under a ½ pound load, more preferably about a10% elongation under a ½ pound load, and more preferably about 14% underthe ½ pound load. An inelastic mesh exhibits less than a 7% elongationunder a ½ pound load.

The mid-portion of the sling mesh (the portion designed to resideunderneath the midurethra) is preferably substantially free of anysilicone coatings. In yet another embodiment (e.g. shown in FIG. 28),the mid-portion of the sling may comprise a non-synthetic material,constructed according to the teachings of U.S. Provisional Patent Appl.No. 60/405,139, filed Aug. 22, 2002. Other suitable synthetic slings aredescribed in published U.S. Pat. No. 2002-0138025-AI, published Sep. 26,2002.

In another embodiment the sling material may have one or more substancesassociated therewith through a process such as coating or they may beincorporated into the raw material of the sling. Examples of appropriatesubstances include, without limitation, drugs, hormones, antibiotics,antimicrobial substances, dyes, silicone elastomers, polyurethanes,radiopaque filaments or substances, anti-bacterial substances, chemicalsor agents, including any combinations thereof. The substances may beused to enhance treatment effects, reduce potential sling rejection bythe body, reduce the chances of tissue erosion, enhance visualization,indicate proper sling orientation, resist infection or other effects.

While the slings are preferably rectangular for treating SUI in females,other shapes are also contemplated. Depending on the treatment addressed(e.g. to provide hammock support for the bladder or bladder neck, or toaddress a rectocele, enterocele or prolapse) the slings may be any of awide variety of shapes. As an example, the sling may be of the generalshape of the slings described and shown in Moir et al., TheGauze-Hammock Operation, Journal of Obstetrics and Gynaecology of theBritish Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968).

FIG. 12 shows a sling 90 with a shape other than a purely rectangularshape. This embodiment of sling 90 includes a mid portion that is widerthan the remaining portions of the sling 90. The mid portion ispreferably placed under the urethra 16, along the mid portion of theurethra.

FIG. 2 illustrates a sling assembly 46 comprising sling 42 and sheath44. Preferably, the overall dimensions of the sling assembly 46,including insertion sheath 44 and sling 42 are sufficient to extend froma superficial incision 400 near the obturator fascia (see FIGS. 4through 8), to an undersurface of the urethra 16 and back to anotherincision 400 in obturator fascia that is opposite the first incision.The size of the sling can take into account the imprecision associatedwith the range of human anatomy sizes. In a preferred embodiment, thesheath length of the assembly of the present invention is approximatelywithin the range of 10 cm to 50 cm, sheath width is approximately withinthe range of 1.0 cm to 2 cm, and sheath material thickness isapproximately within the range of 0.127 mm to 0.203 mm, respectively.The associated sling 42 has a length, width and thickness approximatelywithin the range of 7 cm to 50 cm; 1.0 cm to 2 cm; and 0.508 mm to 0.711mm, respectively.

The sling 42 of the present invention can be implanted without the needfor bone screws. The precise, final location of the sling 42 will dependon a variety of factors including the particular surgical procedure(s)performed, and any preconditions of the patient such as scar tissue orprevious surgeries. For example, it may be preferred to place the sling42 in close proximity to, but not in contact with, a mid portion of theurethra to treat incontinence. Alternatively, the sling may be placednear the bladder neck.

Preferably, the sling 42 has a tensioning filament or suture T asdisclosed, for example, in U.S. Published Pat. Application No US2002/0107430A1. The tensioning suture T may be constructed from apermanent or absorbable material. Also preferably, the sling 42comprises a substantially elastic, polypropylene sling such as a slingconstructed from the polypropylene sling material available in the SPARC Sling System, available from American Medical Systems of Minnetonka,Minn.

FIG. 30 illustrates an embodiment with the tensioning filament Textending along end portions, but not extending along a mid-portion ofthe sling. The sling 42A comprises a polypropylene sling mesh 42A. It isconstructed of polypropylene monofilament that is precut to about 1.1 cmwidth×35 cm length. The tensioning filaments T in this embodiment arefixed at each end to the sling material (e.g. a polypropylene mesh) bywelding (e.g. ultrasonic), knotting, anchoring, adhering (e.g. with andadhesive) or the like. Absorbable tensioning sutures T are threaded intothe length of the sling mesh 42A from each end to allow for tensioningadjustment of the sling mesh 42A after placement in the patient isachieved. The mid portion of the sling mesh 42A is preferably free ofthe tensioning sutures T. For example, approximately 5 mm may separatethe ends of the two tensioning sutures T.

Two plastic sheaths 44A (see FIG. 29) that overlap in the center of thesling mesh cover the sling mesh and protect it during placement. Theplastic covering over the mesh is designed to minimize the risk ofcontamination.

Referring to FIG. 2, a protective sheath 44 is preferred, especiallywhen the sling 42 is elastic. A sheath is particularly desirable whenthe sling is elastic as the sheath 44 assists in introduction of thesling within tissue and avoids damage to the elastic sling material. Thesheath 44 is used during insertion of a synthetic sling 42. After thesling 42 is implanted, the sheath 44 is removed and discarded.Preferably, the protective sheath 44 is constructed of a material thataffords visual examination of the implantable sling material 42 and thataffords convenient passage of the assembly 46 through tissue of thepatient.

In a preferred embodiment, the sheath 44 is made of polyethylene. Othermaterials including, without limitation, polypropylene, nylon, polyesteror Teflon may also be used to construct the sheath 44. The sheath 44should also conveniently separate from the sling material 42 after thesling 42 is implanted without materially changing the position of thesling 42.

The sheath 44 may comprise two elongate, separable sections. Optionally,portions of the sheath 44 may detachably and telescopically overlap nearthe middle portion of the sling or it may be slit (e.g. longitudinallyor perpendicular to the longitudinal axis) to afford convenientseparation.

In another aspect, the present invention comprises a dilator 54 (FIG. 2)for use in a surgical sling procedure. Notably, the dilator is optionalaccording to some aspects of the present invention as, for example, thesling and/or protective sheath may be directly connected to a novelneedle of the present invention by virtue of an eyelet in the needle orother arrangements disclosed in greater detail below.

The dilator 54 comprises a body portion having first end portion 56 andsecond end portion 52 opposite the first end portion 56. The first endportion 56 has surfaces for associating the dilator with a needle (e.g.end 58 of needle 60). The second end portion 52 has sling associationmeans for associating the article with a sling, sling assembly orcomponent thereof. The sling association means may comprise a hole 90.

Preferably, the dilator 54 comprises a short article that dilates aneedle track for ease of sling introduction and positioning within thepatient. End 58 of the needle 60 is preferably keyed to allow forconvenient, secure attachment of the needle 60 relative to the dilator54. Preferably the attachment is permanent.

The kit shown in FIG. 3 includes two dilators 54. The dilators 54atraumatically create and/or expand the passageway through the tissuesfor sling assembly delivery. The dilator 54 is preferably short relativeto a needle 60 for ease of passage of the assembly and to reduce theoverall amount of tissue that is deflected at one time. Preferably, thedilator is less than 2.5 inches in length, and more preferably, it isless than one inch in length, even more preferably, it is less than 0.7inches in length. The maximum radius of a dilator 54 is preferably lessthan 10 mm, more preferably less than 7.5 mm, even more preferably lessthan about 5 mm. The tip or leading end of the dilator 54 is preferablyblunt, as, in preferred embodiments, the leading tip of the dilator 54will pass through tissue that has already been pierced by a needle 60.The dilator 54 may be made from a variety of biocompatible andsterilizable materials including, without limitation, acetal,polycarbonate, polypropylene, Delrin®, Acrylonitrile-Butadiene-Styrene(ABS), polyethylene, nylon and any combination of biocompatiblematerials.

The dilator 54 preferably includes means for associating with a surgicalneedle 60. In a preferred embodiment, the association means affords apermanent affixation between the dilator 54 and the needle 60. By“permanent affixation”, it is meant that it would be very difficult tomanually separate the dilator from the needle after they have becomepermanently affixed. After implantation of the sling 42, to separate thesling 42 from the dilator 54/needle 60, the surgeon cuts an end of thesling 42 as described more fully below. The association means preferablyaffords quick and convenient attachment of the dilator 54 to the needle60 to avoid wasting time in the midst of a surgical procedure. Theattachment should also be secure to avoid separation of the needle 60and dilator 54 while the combination is passed through tissue.

In one embodiment, the means comprises a shoulder surface on the needleand complementary slot surfaces on the dilator 54. Referring to theembodiment of dilator shown in FIG. 2, the dilator 54 may beapproximately 3.1 cm (1.2 inches) in length. The dilator 54 preferablyincludes a gentle taper near its first end 56. The dilator is sized andshaped to provide atraumatic passage through body tissue. The taper andrelatively smooth outer surface of the dilator 54 facilitates atraumaticpassage of the dilator 54 and attached sling assembly 46 through thevarious tissues of the patient. The presence of the dilator 54 allows agentle transition between the diameter of the needle, to the shape ofthe dilator, and finally to the sling assembly 46.

Preferably, the attachment of the dilator 54 to the needle 60 is asubstantially linear fashion, as opposed to a twisting or screw-likeattachment. Preferably, the attachment is a snap-fit attachment to savetime during the surgical procedure.

The second end 52 of the dilator 54 associates the dilator with one endof a sling 42, or sheath 44 or sling assembly 46. The sheath 44 or sling42 is preferably attached to the dilator 54 via a first opening orthrough-hole located near the second end 52 of the dilator 54. In thisembodiment, the opening operates as a universal sling material orassembly attachment point which can receive a variety of materials, suchas fascia, autologous materials, synthetics, biologic tissues and anyother similar tissues, including any combinations.

In the embodiment shown in FIG. 2, the end portion 48 or 50 of one endof the sheath 44 is threaded through the opening of the dilator 54 andsecured to the sheath 44, thereby forming a loop. Alternatively, ends 48or 50 may be fastened onto the sheath 44 via ultrasonic welding,bonding, melting, suturing, sealing or other attachment techniques.Further, the end 52 of the dilator 54 preferably includes a cut-awaysection to provide room to receive sling assembly material to reduce theoverall profile of the sling assembly experienced by tissue during slingpassage. Therefore, when the sheath is attached to the cutaway section,the additional sheath material is not apt to significantly increase therelative thickness, diameter or profile of the dilator 54. Unlike theshowing in FIG. 3, the dilator 54 is preferably pre-attached to thesling assembly 46. In one embodiment, the sling 42 itself may beattached to the dilator, e.g. with a suture threaded through the openingof the dilator and tied to the sling.

One or more longitudinal slots located on the outer surface of thedilator 54 allow the wall of the dilator 54 to expand in a radiallyoutward direction when the first end of the needle 60 is inserted intothe opening of the dilator 54. When a shoulder of the dilator 54 passesthe recess of the needle 60, the wall of the dilator 54 collapses aroundthe needle 60 as the shoulder seats into the recess, thereby securingthe dilator 54 on the needle 60 and blocking separation of the dilator54 and needle 60.

A portion of the dilator 54 includes a taper having a decreasing profiletoward the second end 56 of the dilator 54. The taper preferably gentlycams tissue out of the path of the sling assembly 46 as the slingassembly is inserted in the body. The taper is also sized and shaped toreduce the amount of friction or resistance as the device is drawnthrough the tissues of the patient. The amount of force required tomanipulate the device through the tissues is thereby reduced. This inturn provides the user of the assembly with additional control overdevice insertion and maneuverability through tissue and within thepatient. In addition to tapered profiles, other dilator profiles such asconical, flared, frusto-conical, pyramid-shaped, elliptical or otherapplicable profiles may also be used.

A surgical kit according to the present invention may optionally includeadditional accessories. For example, a surgical drape specificallydesigned for urological procedures such as a sling procedure may beincluded in a kit of the present invention. Such a drape is disclosed inpublished U.S. Pat. Appl. No. 2002-078964-A1. Alternatively, an articlefor objectively setting tension of the sling, such as one of thearticles described in published U.S. patent application Ser. No.09/968,239, filed Oct. 1, 2001 may be included in the kit.

The kits according to the present invention preferably include at leasttwo needles. In some instances the needles may be substantiallyidentical, in other instances, they may be different. Two or moreneedles reduce the need to reuse a non-sterile needle at a differentlocation with a patient, thereby eliminating cross contamination issues.Additional needles, handles, dilators and other elements may also beincluded for surgical convenience, for avoidance of contamination fromone portion of the body to another, for ease of manufacturing orsterilization or for surgical requirements. For example, two differenttypes of needles may be included in a kit. One type of needle may besuitable for an outside-in (e.g. from the skin incision toward a vaginalincision) approach. Another type may be suitable for an inside-out (e.g.from the vaginal incision toward a skin incision) approach. Surgeonsthat prefer an approach dictated by the surgeon's dominant hand mayprefer this embodiment. Alternatively, a universal needle (e.g. onesuitable for both an inside out and an outside in approach) may beutilized.

FIG. 53 illustrates a system 101 for use in an inside-out procedure. Thesystem 101 comprises a pair of needles 109 that are sized and shaped forthe inside-out approach. The system 101 also includes a sling assemblycomprising a sling 111, and protective sheath 113. The sling assemblymay be permanently attached to the needles 109 at ends 117.Alternatively, the needle 109 can include specially shaped structure(e.g. an eyelet) near end 117 that affords association between theneedle 109 and sling or sling assembly after passage of the needle 109.The system 101 may optionally include releasable handle portions 119that can be releasably attached to the needles 109 at ends 121.

FIG. 54 illustrates a system 102 for use in either an inside-outprocedure or an outside-in procedure. The system 102 comprises a slingassembly 146 having a sling material 142, a sheath 144 and dilators 154.The system includes a handle portion 164 that is at least partiallyreusable. Needles 162 are suitable for either an inside-out or outsidein procedure. The ends 158 of the needles 162 may be attachable toeither a dilator 154 or the handle portion 164. Alternatively, theneedles may be attachable to the implantable material itself or a slingand protective sleeve assembly without any dilator.

The system 102 allows the needles to be passed through tissue withoutrequiring that they be attached to a sling or sling assembly. Thus, ifthe initial passage is not deemed to be optimum, the needles may berepassed without subjecting the sling or sling assembly to damage duringthe initial passage.

FIGS. 55-57 sequentially illustrate use of the system 102 using aninside-out approach. FIG. 55 illustrates passage of the needles 162using inside-out approaches. The handles 164 are optional. If they areused, they are removed once the needles 162 have emerged from the skinincision. FIG. 56 illustrates the needles 162 after the handles 164 havebeen removed, in preparation for attachment of a sling assembly 146 onthe ends 158 of the needles 162 previously occupied by the handles 164.FIG. 57 illustrates the system 102 during implantation of the sling.

FIG. 58 is a schematic illustration of the system 102 used in aninside-out approach (the right side of the patient) and an outside-in(the left side of the patient) approach. This combination maybeutilized, by a right-handed surgeon who prefers to pass the leading edgeof the needle with his or her dominant hand. Alternatively, thecombination may be reversed for a left handed surgeon. The remainder ofthe surgical procedure may be substantially identical to that depictedin FIGS. 56 and 57. Notably, the handle 164 utilized on the right sideof the patient's body may optionally be placed on the other side of theneedle after it emerges from the patient's body to conveniently assistthe surgeon in moving the needle 162 and sling assembly 146 through thetissue.

FIGS. 59-61 sequentially illustrate the system 102 used in outside-inapproaches. FIG. 59 illustrates the needles 162 inserted initiallythrough the patient's skin and thereafter emerging from a vaginalincision. FIG. 60 illustrates the system 102 just prior to attachment ofa sling assembly 146. FIG. 61 illustrates the system 102 duringimplantation of the sling.

Referring to FIG. 62, there is shown another system 200 according to thepresent invention. The system 200 comprises a needle 262 suitable for anoutside-in approach on the left side of the patient's body andassociated handle 264. The system 200 also includes a sling assembly 246comprising a sling 242, protective sheath 244 and dilator 254 at oneend. The dilator 254 is designed to mate with the end 258 of the needle262. At the other end of the sling assembly 246, a needle 265 may bepermanently attached to the sling assembly 246. The needle 265 is sizedand shaped to be suitable for an inside-out approach on the right sideof a patient's body. The needle 265 includes a leading end 266 suitablefor that purpose. The leading end 206 may be substantially blunt or,alternatively somewhat sharpened. The system 200 is particularlysuitable for a surgeon that desires to initially pass needles with hisor her dominant hand. The depicted system 200 is suitable for a righthanded surgeon. A mirror image or reverse system is particularlysuitable for a left handed surgeon that desires to initially pass aneedle with his or her left hand.

Optionally, the system 200 could include a detachable handle for theneedle 265 to assist in passage of the needle 265. Also optionally, theneedle 264 may be omitted from the system. Instead, the needle 265 maybe used to pass the sling initially using an outside-in approach on oneside of the body and then continuing to insert the sling using an insideout approach on the other side of the body.

In a preferred embodiment, a kit comprises two surgical instruments suchas those shown in FIGS. 15-22, and a polypropylene sling mesh assemblywith attached dilators as shown in FIG. 28. Such a kit may be providedfor the placement of a pubourethral sling for the treatment of femalestress urinary incontinence (SUI) resulting from urethral hypermobilityand/or intrinsic sphincter deficiency.

The individual elements of the kits of the present invention may bepackaged together, separately or in subassemblies depending on a varietyof factors such as shelf life and sterilization requirements. They maybe assembled at the manufacturing location or at the healthcarelocation. Any suitable sterilization procedure may be utilized tosterilize the contents of a kit. Suitable sterilization techniquesinclude, but are not limited to steam, ethylene oxide, electron beam,vapor (e.g. hydrogen peroxide or peracetic acid), gamma or plasmaprocedures. For example, the surgical instrument may be reusable orsingle use devices.

FIG. 11 shows another embodiment of the present invention. In thisembodiment, the needle 60 acts as a surgical guide needle (e.g. with adiameter of about 4 nun, or less, preferably about 3 mm) for arelatively larger sling transport needle 604 (e.g. with a diameter ofabout 5 mm or less). Preferably, the sling transport member has a slingassembly 610 (e.g. a sling mesh and insertion sheath) attached thereto.Alternatively, the sling transport needle 604 may have a moreexaggerated hook shape, similar to the shape shown in PCT WO 02/39890.

The guide needle 60 serves a different purpose than the surgicaltransport needle 604. The surgical guide needle 60 is preferably smalland has a blunt tip. The blunt tip is initially inserted throughincision 400 adjacent obturator fascia and then through a vaginalincision. Inserting a small, blunt needle in this fashion provides thesurgeon with addition control in maneuvering through the anatomy of apatent and in avoiding sensitive tissue.

A surgical kit according to an aspect of the present invention mayinclude a dilator 54 for placement on the end of needle 60. The slingtransport needle 604 may optionally include a sharp tip. The dilator 54receives the tip of the needle 604. Pushing sideways on the slingtransport needle 604 with one hand while steering the tip of the needle604 by holding guide needle 60 with the other hand may be used toimplant the sling.

Alternatively, the dilator 54 can include surfaces for firmly engagingand attaching to needle 604. Those surfaces can include mechanicalinterlocking structures, grasping structures or interlocking structures.As a result, the needle 60 need not have specially shaped surfaces 58for engaging the dilator and can instead have cylindrical surfacesadapted to be received within the dilator.

Referring to FIGS. 15, 16, 17 and 18, there is shown a novel needle 60Raccording to the present invention. The needle 60R is particularlysuitable for passage on the right side of a patient's body, initiallyfrom an incision in the region of the patient's obturator foramen andsubsequently emerging through a vaginal incision. The needle 60Rincludes a handle 64R and a leading end portion 62R. Referring to FIG.27, the leading end portion 62R includes a substantially blunt distaltip 63R and specially designed surfaces 67R and 65R suitable for matingwith complementary surfaces on a dilator or connector (described in moredetail below). Notably, in one aspect of the present invention, a novelneedle of the present invention may utilize an eyelet near its distaltip to afford a suture attachment to a sling or sling assembly withoutthe use of a dilator.

As shown in FIGS. 15-18, the needle 60R has substantial structure inthree dimensions, as opposed to, for example, the substantially flatneedle shown in FIG. 1 (or an Emmet needle) that only includessubstantial structure in two dimensions. Having substantial structure inthree dimensions helps the surgeon pass the needle through the obturatorforamen and subsequently through a vaginal incision by affording greatersurgeon control. The handle of the needle allows the surgeon to move thedistal end of the needle with an ergonomic wrist roll action

FIGS. 15A, 16A, 17A and 18A show another embodiment of novel needle 60R′that is similar, but not identical to the needle 60R. The needle 60R′ isalso particularly suitable for passage on the right side of a patient'sbody, initially from an incision in the region of the patient'sobturator foramen and subsequently emerging through a vaginal incision.

FIGS. 19, 20, 21 and 22 show another novel needle 60L according to thepresent invention. The needle 60L is particularly suitable for passageon the left side of a patient's body, initially from an incision in theregion of the patient's obturator foramen and subsequently emergingthrough a vaginal incision. The needle 60L includes a handle portion 64Land a leading end portion 62L. Like the needle 60R, the needle 60Rincludes substantial structure in three dimensions.

FIGS. 19A, 20A, 21A and 22A show another embodiment of novel needle 60L′that is similar, but not identical to the needle 60L. The needle 60L′ isalso particularly suitable for passage on the left side of a patient'sbody, initially from an incision in the region of the patient'sobturator foramen and subsequently emerging through a vaginal incision.

Yet another embodiment of novel needle is shown in FIG. 20B. The novelneedle 64L″ is substantially similar to the needle 64L′, except that thetip T of the needle lies substantially in the plane P of the handle H ofthe needle 64L″. It is believed that such an arrangement of the elementsmay assist some surgeons in conjuring a mental image of the location ofthe tip T of the needle 64L″ relative to the body while the needle isbeing passed through a patient outside the surgeon's direct vision. Thearrangement of the tip and the handle affords visual feedback concerningthe approximate location of the tip of the needle when the tip is notunder direct vision. Instead of a snap-in feature for connection to adilator, this needle 64L″ includes an eyelet E for threading a suture sothat the needle 64L″ can be tied to an implantable material or assemblysuch as a knitted polypropylene sling with an associated sheath.

FIGS. 63 through 67 show various embodiments of sling assembliessuitable for use in the present invention. These assemblies may be usedin systems that do not include a dilator. FIG. 63 illustrates a slingassembly 300 having sutures 306 for threading through an eyelet of aneedle to associate the assembly 300 with a needle. The assembly 300 maycomprise a composite assembly with synthetic portions 308 and anon-synthetic mid portion 309 connected with fasteners 303.

FIG. 64 shows a sling assembly 320 comprising only a synthetic meshmaterial 322. Sutures 6 may be threaded through an eyelet of a needle toassociate the assembly 320 with a needle. Optionally, a sheath may beadded to the assembly 320, especially when the mesh 322 is elastic.

FIG. 65 illustrates a sling assembly 330 comprising a non-syntheticsling 332. Sutures 336 may be threaded through an eyelet of a needle toassociate the assembly 330 with a needle. Optionally, suture anchors orpled gets may be utilized to avoid suture pull through.

FIG. 66 illustrates a sling assembly 340 comprising a sling mesh 342 anda sheath 344. In this embodiment, the ends of the sling mesh 342 may beattached to the ends of the sheath 340 by welding, suturing, or othersuitable means. Sutures 346 may be tied about the ends of the sheath 344to form a dilator-like structure for pushing tissue out of the way ofthe assembly 340 during implantation. The sutures 346 may be threadedthrough an eyelet of a needle to associate the assembly 340 with aneedle. FIG. 66 also shows a tensioning suture, but this is optional andcan be omitted.

FIG. 67 illustrates another sling assembly 350 comprising a syntheticmesh 352 and a sheath 354. Sutures 356 may be threaded through an eyeletof a needle to associate the sling 352 with a needle. Sutures 358 may betied about the ends of the sheath 354 to form a dilator-like structurefor pushing tissue out of the way of the assembly 350 duringimplantation. FIG. 67 also shows a tensioning suture T′, but this isoptional and can be omitted.

Preferably, the handles of the surgical instruments shown in FIGS.15-20B includes indicia indicating the proper side of the patient. Forexample, the indicia may be any suitable information conveying word,symbol or depiction. The indicia may simply be “right” or “left.” Forthose instruments designed for use on the right side of the patient, theindicia may include a drawing similar to FIG. 32. For the instrumentsdesigned for use on the left side of the patient, the indicia mayinclude a drawing similar to FIG. 33.

The various embodiment of three dimensional needles described abovepreferably include a substantially straight spacer portion emerging froman end of the handle portion preferably along the handle axis. Thishelps afford convenient passage of the needle using an ergonomic wristroll adopted by some surgeons. The three dimensional needles alsoinclude a structure that can be described as a variable spiral portionextending from the distal end of the straight spacer portion. As shown,the spiral portion is preferably variable as the angle of the spiralportion changes between the end of the straight portion and the distalend of the needle. The shape of the spiral portions help avoid overinsertion of the needle into the body which helps avoid damage to thesensitive structures in this region of the body.

The variable spiral portions of the three dimensional needles havetissue clearance depth TCD of greater than about 1.5 inches and lessthan about 2.5 inches, more preferably the tissue clearance depth isbetween 1.75 inches and about 2.25 inches, even more preferably it isabout 2 inches. The tissue clearance depth TCD is the distance betweenthe end of the straight spacer portion and a point along an extension ofthe axis of the straight spacer portion which is defined by a line thatis normal to the axis and that intersects the distal tip of the needle.The tissue clearance depth TCD helps space the distal end of the needlefrom the distal end of the straight portion to reduce interference inneedle passage by the distal end of the straight portion.

The variable spiral portions of the three dimensional needles have amaximum width MW that is preferably great enough to afford passagearound the inferior pubic ramus and through the natural opening of thepubic bone, but small enough to avoid sensitive structure in this regionof the body. Preferably, the maximum width MW is greater than about 1.25inches and less than about 3 inches, more preferably, it is betweenabout 2 and about 2.225 inches and more preferably, it is about 2.15inches.

Referring to FIGS. 23, 24, 25, 25A and 26, there is shown a noveldilator 54S according to another aspect of the present invention. Thedilator 54S includes a hole 90S for receiving a sling or a sheath orboth in order to associate the dilator with a sheath.

Due to the more tortuous path associated with a trans obturator routeand the tighter radial passage, a shorter dilator is preferred to reducetissue trauma and afford convenient, easy passage. Rotation of a helicalneedle can cause a substantially straight dilator to skid or plowthrough tissue instead of moving in a direction parallel to thelongitudinal axis of the dilator. A shorter dilator will reduce tissuetrauma associated with such plowing or skidding. Alternatively, aslightly curved or arcuate dilator may be used to reduce plowing orskidding.

The length L of a substantially straight dilator 54S is substantiallyshort, preferably less than about 30 mm (1.2 inches) more preferablyless than about 18 mm, 0.7 inches. The outermost diameter D of thedilator 54S is preferably less than about 6 mm 0.24 inches, morepreferably less than about 5 mm, even more preferably, less than about 4mm. The dilator 54S preferably has surfaces 51S that provide a smoothtransition between the needle (e.g. 60L) and the sling assembly. Theangle theta is preferably less than about 15 degrees and more preferablyless than about 12 degrees.

In one embodiment of the present invention, one substantially straightdilator 548 may be used with either a left or a right side needle.Preferably, such a combination includes a distal end of the needle thatis substantially straight. This length (e.g. L″ in FIG. 26A) ispreferably short, preferably less than 0.9 inches, more preferably lessthan 0.8 inches, more preferably about 0.42 inches. In one embodiment,the length L′ in FIG. 25 may be 0.3 inches.

It is noted that the dilator is preferably capable of being “permanentlyaffixed” to the needle. Preferably, the needle is attached to thedilator without a suture. FIG. 26A illustrates one example of apermanently affixed needle and sling assembly. By “permanentaffixation”, it is meant that it would be very difficult to manuallyseparate the dilator from the needle after they have become permanentlyaffixed. After implantation of the sling, to separate the sling from thedilator/needle subassembly, the surgeon cuts an end of the slingassembly (e.g. a cut is made through the mesh and protective sleeve) toseparate the mesh from the needle/dilator subassembly. The connectionbetween the needle and dilator preferably affords quick and convenientattachment of the dilator to the needle to avoid wasting time in themidst of a surgical procedure. The attachment should also be secure toavoid separation of the needle and dilator while the combination ispassed through tissue.

To accomplish the preferred attachment, the dilator 548 includes aninternal stop surface 57S that is complementary with specially shapedsurfaces on a needle (e.g. 62R, FIG. 27). As best seen in FIG. 26A, thestop surface 57S is designed to engage complementary shoulder surface(e.g. 65R, FIG. 27) to achieved the desired convenient, but permanentaffixation.

Also preferably, the needle is attached to the dilator without anyscrew-type connector. Preferably, the connection is a snap-fit, quickconnection for secure, convenient use by the surgeon. Also preferably,the connection is a press on connection that does not requiresubstantial rotation of elements (especially elements that are withinthe body) as such a connection is less likely to displace a needle orotherwise injure the patient.

Referring to FIG. 28, the dilators 54S may form a portion of a slingassembly that includes synthetic sling end portions 42A′, sheaths 44A′covering at least some of the sling end portions 42A′ and anon-synthetic mid-portion 45′. A composite sling assembly may beassembled by the surgeon or provided preassembled using the teachings orcomponents of published U.S. Pat. Application Nos. 2002/0147382A1 or2002/0082619A1.

In another aspect, the present invention comprises the ornamental designfor a surgical instrument, as shown in FIGS. 39 through 45 and describedin the Brief Description of the Drawings.

In another aspect, the present invention comprises the ornamental designfor a surgical instrument, as shown in FIGS. 46 through 52 and describedin the Brief Description of the Drawings.

The broken line showing in FIGS. 39-52 are for illustrative purposesonly and form no part of the claimed design.

The above-described surgical instruments may be disposable or reusable.Optionally, portions of the surgical instrument may be reusable(sterilizable) and other components may be disposable.

EXAMPLES OF SURGICAL PROCEDURES

Several methods are contemplated herein. Although the methods of use asdisclosed herein generally relate to female incontinence conditions andtreatments/procedures, male incontinence conditions andtreatments/procedures are also included within the scope of the presentinvention. Further, the term “urethra,” with respect to slingpositioning, is used for brevity and reader convenience. It should benoted that the present invention is particularly suitable for placing asling in a therapeutically effective position. The method may beutilized to support a variety of structures at different anatomicallocations. Variations of these methods may occur due to individualsurgeon's techniques or a patient's particular anatomy.

Referring to FIGS. 4 through 10, a preferred embodiment of surgicalprocedure is disclosed. The present invention utilizes an obturatorpassage of the needle, preferably in a direction from the anterior tothe posterior side of the pubic bone. An obturator approach affords asling procedure where previous scarring in the region of the retropubicspace or other anatomical features would prevent or restrict atraditional pubovaginal sling procedure. An obturator approach is alsolikely to avoid bladder perforations, a possible but rare complicationwith some prior art pubovaginal procedures. It may also be moreconvenient to conduct a concomitant repair (e.g. cystocele repair) witha sling inserted with a side approach as the sling is placed in a morehorizontal position (e.g. see FIGS. 9 and 10) than the U-shaped slingprocedures of the prior art.

Initially, the patient is placed under local, spinal or generalanesthesia. A catheter 2 (e.g. Foley) may be inserted through theurethra 16. A small incision (e.g. a transverse incision) is made in theanterior vaginal wall 20 of a patient followed by a transurethraldissection. The amount of dissection may vary according to surgeonpreference. Preferably, dissection is sufficient to allow the surgeon'sfinger to meet the end 58 of the needle 60 just after it passes throughthe obturator fascia.

Two small stab incisions 400 are also made near the obturator fascia toafford needle entry. Notably, the precise location of the stab incisions400 may vary according to surgeon preference. For example, some surgeonsmay place the incision adjacent the obturator opening of the pubic bone.Other surgeons may slightly offset the incision in order to use the biasprovided by the patient's tissue to urge the tip of the needle in adirection toward the posterior surface of the pubic bone.

Referring to FIG. 4, the end 58 of needle 60 is shown just passing anincision 400 on the patient's right side. The surgeon's finger isinitially placed in the vaginal incision sufficient to meet the end 58of the needle 60 after it passes through the obturator fascia and theobturator foramen 3 (see FIG. 9). A path for the needle 60 through theobturator foramen 3 that is substantially free of vascular and nervepassages is selected. To select the path, the surgeon preferablyinitially identifies the anatomical structures of the pelvis such as theischial tuberosity and obturator foramen 3 by palpation of the tissue.

If optional handle 64 is used, it may be adjusted relative to needle 60according to surgeon preference and securely associated with the end 62of the needle 60. FIG. 5 shows the end 58 of needle 60 just passing anincision 400 on the patient's left side.

Preferably, after the end 58 of the needle 60 meets the surgeon'sfinger, the surgeon seeks to use the posterior portion of the patient'spubic bone as an anatomical guide to controllably move the end 58 of theneedle toward the vaginal incision and to help avoid damagingstructures. The surgeon exploits the tactile feel provided by theposterior portion of the pubic bone to controllably pass the end of theneedle 58. This approach is preferred as it helps keep the needle 60away from the bladder and other vulnerable tissues.

FIG. 6 illustrates the needle of FIG. 5 as it emerges from a vaginalincision. The shape and size of needles 60 help provide precise passageof the needles 60 to the vaginal incision. The steps described above arerepeated as needed for both sides of the urethra 16. FIG. 6 alsoillustrates one side of a sling assembly 46 prior to association withthe needle 60.

FIG. 7 is a perspective view of one side of a sling system after it isassociated with needle 60. The dilators 54 of the sling assembly 46 arepreferably snapped irreversibly into place on the needles 60 for asecure connection. Next, if a synthetic sling assembly is used, theplastic sheath 44 is oriented so that an optional center orientationindicia (e.g. a blue mark) is facing away from the surgical field,toward the surgeon.

After the dilators 54 are attached to the needles 60, the sling assembly46 is properly oriented so that the sling assembly 46 is not twistedwhen attached to the dilators 54. After the dilators 54 and slingassembly 46 are properly positioned, dilators 54 and sling assembly 46are pulled through the tissues of the patient.

Referring to FIG. 8, once the dilators 54 are securely attached, theneedles are pulled through the incisions 400, taking care to avoidcontact with sensitive tissue. The sling is then clamped with surgicalclamps (not shown). During this portion of the process, the attacheddilators 54 and sling assembly 46 are atraumatically pulled through theneedle paths, advancing the sling assembly 46 adjacent to and beneaththe urethra 16 or target site. A portion of each end of the slingassembly 46 extending beyond the incisions 400 is clamped and then cutto release the needles 60 and attached dilators 54.

The sling is placed in a therapeutically effective position. FIGS. 9 and10 show one example of a therapeutically effective position. Otherpositions are contemplated herein. The precise anatomical position willdepend upon a variety of factors including the type and degree ofanatomical damage or insufficiency, location of significant scar tissue,whether the sling procedure is combined with other procedures and othersurgeon decisions. Typically, the sling is placed midurethra, withouttension, but in position to support the midurethra. Alternatively, thesling could be placed to support the bladder neck and/or UV junction.

Once the sling assembly 46 is carefully positioned under the midurethraor target site to provide sufficient support to the target site, theoverlapping portion of the sheath 44 located near the center of thesling assembly 46 and an optional tensioning member (i.e. tensioningfilament) may then be used to center and properly position the slingassembly 46 under the midurethra. The sheath 44 is then removed.

Sling tension may be tightened by placing a device, such as a clamp,across one or both ends of the sling 42. Generally, the surgeon graspsthe mesh and tensioning filament together adjacent the incision 400 andpulls to increase the degree of tightness of the mesh.

After the dilators 54 are trimmed off, the plastic sheath 44 is removedfrom the sling mesh 42 by pulling on both sides of the sheath 44,preferably one at a time. Optionally, to avoid overtightening the slingmesh 42 while removing the sheath 44, a forceps or other bluntinstrument may be placed between the sling and the urethra.

FIGS. 9 and 10 illustrate one embodiment of the final placement of thesling 42 relative to anatomical structures such as the pubic bone,urethra and vagina. The sling is flatter than the V-shaped slings of theprior art which extend to the rectus fascia of the patient's abdomen.

In another embodiment of the invention, shown with reference to FIG. 11,a method includes the steps of: providing a surgical kit comprising atleast one guide needle 60 constructed for an obturator approach, and atleast one sling transport needle 604 with a sharp tip, a sling 610attached to the sling transport needle 604, and a dilator 54 having tipreceiving surfaces for receiving the sharp tip of the sling transportneedle 604. The needle 60 has a relatively small diameter (e.g. lessthan 4 mm). The method includes the steps of creating at least onevaginal incision, creating two obturator stab incisions, and initiallypassing a guide needle 60 through the obturator incision and thenthrough the vaginal incision. The dilator 54 is then attached orassociated with the needle 60.

Needles 604 are initially guided through a vaginal incision and towardone of the obturator incisions 400. Guiding the sharp tip of the largesling transport needle 604 in this fashion is believed to help avoidcontact between the sharp tip of needle 604 and sensitive structures.Optionally the adapter with receiving surfaces may be integrally formedin the needle 604 to avoid the need to separately attach the adapter tothe needle 604.

FIG. 4A shows an alternative step according to an aspect of a methodaccording to the present invention. This illustrates a method whereinthe needle 60 of FIG. 1 is initially inserted through a vaginal incisionand then emerges from a skin incision. In this embodiment, the slingassembly may then be attached to the end of the needle previouslyoccupied by a removable and repositionable handle 64. The handle 64 maythen optionally be placed on the other end of the needle 60 to assistthe surgeon in passing the sling assembly and needle through the body.This is shown by the arrow in FIG. 4A adjacent the dotted line showingof the handle 64.

The method preferably includes the step of removing the handle 64 andattaching an end of the sling assembly to the end of the needlepreviously occupied by the handle 64. The needle and attached slingassembly is then passed completely through the body, in substantiallythe same direction as the initial insertion, to place one side of thesling assembly. As a result, it can be seen that the needle 60 is auniversal needle (i.e. one that can be utilized for either an“outside-in” surgical approach or an “inside-out” approach).

Referring now to FIGS. 31-38, there is shown another embodiment ofmethod according to the present invention. This embodiment is believedto be suitable for patients under local, regional or general anesthesia.This embodiment utilizes needles specially shaped for use on apredetermined side (e.g. right or left) of the patient.

A small incision may be made in the anterior vaginal wall followed bypariurethral dissection. Two small stab incisions are also made abovethe obturator foramen for instrument passage.

The patient is preferably placed in a modified lithotomy position withhips flexed, legs elevated. The bladder is emptied and a weightedvaginal retractor may be used.

The surgeon palpates the inferior portion of the ischiopubic ramus,palpates the edge of the bone and notes where the ischiopubic branchgets wider and the obturator membrane is tactily sensed. Just below thislocation and lateral to the bone is a preferred mark for the skinincisions. The surgeon preferably confirms that both marks lie in astraight line approximately at the level of the clitoris.

In the anterior wall of the vagina, the surgeon may draw a vertical markapproximately 0.5 cm below the meatus. The incision may be approximately2 cm in length. An Allis forceps may be placed on the incision margin toexpose the incision.

The surgeon incises the vaginal wall and extend the dissection laterally(pariurethral) with, for example, a Metzenbaum scissors. The surgeonthen may dissect the pariurethral attachment to the vagina. The surgeonmay then insert the tip of a blunt instrument (e.g. the Metzenbaumscissors laterally), spread and advance the scissors until the tip ofthe scissors touches the inferior portion of the bone (about 1-1.5 cm).This may be accomplished bilaterally. The vaginal dissection ispreferably large enough for a finger tip to enter in both directions.

The instrument is then passed through the obturator foramen. The surgeonpreferably palpates the interior portion of the ischiopubic ramus,palpates the edge of the bone and preferably moves his or her fingercephalad until muscle firmness is felt. Just below this location andlateral to the bone may be the mark for the skin incisions. The surgeonmay confirm that both marks lie approximately in a straight line at thelevel of the clitoris.

The surgeon may then insert the index finger into the vaginal dissectionand probe to the ipsilateral outer obturator foramen mark to confirmneedle path. The surgeon makes a small vertical skin incision on thesame side over the skin mark denoting the foramen. If patient sidespecific instruments are used (e.g. those shown in FIGS. 15-22), theinstrument designated for the patients left side 60L may be removed fromthe package. The surgeon points the instrument tip perpendicular to theskin and proceeds to the level of the obturator fascia.

With a finger in vaginal incision, the surgeon moves the fingerlaterally to meet the needle tip (see FIG. 35). When passing the needle60L on the patient's left side, the surgeon preferably keeps his or herright hand on the needle handle and left index finger in the vaginalincision. The surgeon's left thumb may optionally be on the outsidecurve of the needle 60L to control the needle movement. The surgeon'sleft thumb preferably pushes the needle through the muscles andobturator fascia. The needle tip preferably penetrates until resistanceof the tissue stops—about 0.5 cm.

The surgeon then preferably immediately locates the ischial pubic ramuswith the needle tip 62L and rotates the needle handle 64L (see FIG. 33)to allow the needle to follow the posterior ischial pubic ramus surface.The index finger tip should palpate the needle tip. If not, the surgeonshould move the needle to meet the finger tip. If the needle tip cannotbe located, then the needle should be withdrawn just behind the ischialpubic ramus and advanced again.

Using the index finger, the surgeon preferably guides the instrument tipmedially towards the vaginal incision until the instrument tip extendsthrough the incision (see FIG. 36).

The above steps are repeated on the patient's right side. See FIGS. 32and 34. Cystoscopy may not be required but can be done at the surgeon'sdiscretion.

The surgeon then attaches the dilating connectors (that are pre-attachedto the sling mesh) to the ends of the instruments 60L and 60R thatemerge from the vaginal incision. One dilating connector 54S should beattached to each of the instruments 60L and 60R on the ends protrudingfrom the vagina. If optional blue markings are used on the slingassembly, the surgeon orients the blue markings on the sheath facingoutward, away from the urethra 16. The surgeon may use the blue markingsto help ensure that the sling mesh lies flat and that the mesh is nottwisted prior to attaching the second dilator 548 as the dilators cannotbe removed once they are snapped into place.

The surgeon then pulls the assembly through the lateral incision. Thisis shown for the left side of the patient's body in FIG. 37. Next thesurgeon cuts the sling mesh just below the level of the connector anddiscards the needle and dilator. In FIG. 38, this has been accomplishedfor the portion of the system on the right side of the patient's body.

The surgeon preferably keeps the blue centering marks on the plasticsheath in the midline. This is repeated on the contralateral side.

If vaginal retraction has been used, it should be removed to adjust thetension of the sling. The sling may be finely tensioned by placing ablunt instrument (e.g. a Metzenbaum scissors or small instrument)between the sling and urethra.

The surgeon removes the plastic protective sheaths 44A and discardsthem.

Under spinal or regional anesthesia, the position of the sling can beimproved by the cough test after filling up the bladder, at thediscretion of the surgeon.

To loosen the mesh, the surgeon places an instrument (e.g. Metzenbaumclamp) between the sling mesh and the urethra. The surgeon ensures thatboth the mesh and the tensioning suture are located beneath the clamp.The clamp may be used to pull down and loosen the sling mesh as desired.

To tighten the sling mesh, the surgeon places a clamp (e.g. hemostat)across the sling mesh at the lateral incisions 400. The surgeon ensuresthat both the tensioning suture and the complete width of the sling arecaptured within the clamp. The sling mesh may be rolled around the clampto improve the grip. The surgeon pulls up to tighten the sling mesh asdesired. If needed, this can be repeated on the contralateral side.

To complete the procedure, the surgeon trims the sling mesh at the levelof the subcutaneous tissue. A multi-layer closure of the vaginalincision and the skin incisions may then be completed.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A surgical instrument for treating a pelvic disorder, the instrumentcomprising: a handle portion elongate along a handle axis; and a needleportion connected to said handle portion, and having a spacer portionalong the handle axis and a distal end, the needle portion having ahelical portion that extends from the spacer portion, wherein thehelical portion is sized and shaped to extend from an incisionsubstantially adjacent an obturator foramen of a patient, through theobturator foramen along a path in a region between the superior pubicramus and the inferior pubic ramus to an incision below the patient'surethra, wherein said needle is configured to be interfaceable with animplantable material that treats the pelvic disorder.
 2. The instrumentof claim 1, wherein the needle portion has a structure near the distalend that associates the instrument with an implantable materialconfigured to treat incontinence.
 3. The instrument of claim 1, whereinthe structure comprises an eyelet.
 4. The instrument of claim 1, whereinthe handle portion is elongate defining a mid plane, and the distal endof the needle portion includes a distal tip situated substantially nearan extension of the mid plane that is spaced from the handle portion. 5.The instrument of claim 1, wherein the needle portion includes asubstantially circular cross-sectional shape with a diameter less thanabout 4 mm.
 6. A surgical assembly for treating a pelvic disordercomprising: a surgical instrument having a handle portion; a needleportion connected to said handle portion, said needle portion having adistal end and having a first portion that is sized and shaped to extendbetween an incision substantially adjacent an obturator foramen of apatient through the obturator foramen along a path in a region betweenthe superior pubic ramus and the inferior pubic ramus to an incision ina position below the patient's urethra; an implantable material; theneedle portion having structure near the distal end to associate thesurgical instrument with the implantable material; and a dilator with anengagement surface to connect the dilator to the surgical instrument,the dilator operatively associated with the implantable material,wherein the structure of the needle portion near the distal end thatassociates the surgical instrument with the implantable materialincludes a surface complementary with the engagement surface of thedilator.
 7. A surgical assembly for treating a pelvic disordercomprising: a surgical instrument having a handle portion; a needleportion connected to said handle portion, said needle portion having adistal end and having a first portion that is sized and shaped to extendbetween an incision substantially adjacent an obturator foramen of apatient through the obturator foramen along a path in a region betweenthe superior pubic ramus and the inferior pubic ramus to an incision ina position below the patient's urethra; an implantable material; and theneedle portion having structure near the distal end to associate thesurgical instrument with the implantable material; wherein the needleportion is sized and shaped for a predetermined side of the patient, andthe instrument includes indicia indicating the predetermined side of thepatient.
 8. A surgical assembly for treating a pelvic disordercomprising: a surgical instrument having a handle portion; a needleportion connected to said handle portion, said needle portion having adistal end and having a first portion that is sized and shaped to extendbetween an incision substantially adjacent an obturator foramen of apatient through the obturator foramen along a path in a region betweenthe superior pubic ramus and the inferior pubic ramus to an incision ina position below the patient's urethra; an implantable material; and theneedle portion having structure near the distal end to associate thesurgical instrument with the implantable material; and a sheath.
 9. Asurgical assembly for treating a pelvic disorder comprising: a surgicalinstrument having a handle portion; a needle portion connected to saidhandle portion, said needle portion having a distal end and having afirst portion that is sized and shaped to extend between an incisionsubstantially adjacent an obturator foramen of a patient through theobturator foramen along a path in a region between the superior pubicramus and the inferior pubic ramus to an incision in a position belowthe patient's urethra; an implantable material; and the needle portionhaving structure near the distal end to associate the surgicalinstrument with the implantable material, the surgical assembly furthercomprising a dilator having an overall length of less than about 0.7inches, and the dilator and the needle portion comprise engagementsurfaces for associating the dilator with the needle portion.
 10. Thesurgical assembly of claim 9, wherein the structure comprises an eyelet.11. The surgical assembly of claim 9, further comprising a dilator withan engagement surface to connect the dilator to the surgical instrument,the dilator operatively associated with the implantable material,wherein the structure of the needle portion near the distal end thatassociates the surgical instrument with the implantable materialincludes a surface complementary with the engagement surface of thedilator.
 12. The surgical assembly of claim 9, wherein the needleportion is sized and shaped for a predetermined side of the patient, andthe instrument includes indicia indicating the predetermined side of thepatient.
 13. The surgical assembly of claim 9 wherein the surgicalassembly further comprises a sheath.
 14. The surgical instrument ofclaim 9 wherein the portion comprises a curve comprising an arclength inthree dimensions.
 15. The surgical instrument of claim 14 wherein theportion comprises a helical curve.
 16. A surgical assembly for treatinga pelvic disorder comprising: a first surgical instrument that is usedon a right side of a patient, wherein the first surgical instrumentcomprises a handle portion and a needle portion, the needle portionhaving a first portion that is sized and shaped to extend from anincision substantially adjacent an obturator foramen on the right sideof the patient through the obturator foramen along a path in a regionbetween the superior pubic ramus and the inferior pubic ramus to anincision in a position below the patient's urethra; and a secondsurgical instrument that is used on a left side of a patient, whereinthe second surgical instrument comprises a handle portion and a needleportion, the needle portion having a first portion that is sized andshaped to extend from an incision substantially adjacent an obturatorforamen on the left side of the patient through the obturator foramenalong a path in a region between the superior pubic ramus and theinferior pubic ramus to an incision in a position below the patient'surethra.
 17. The surgical assembly of claim 16, wherein the firstsurgical instrument includes indicia indicating the first surgicalinstrument is for use on the left side of the patient.
 18. The surgicalassembly of claim 16, further comprising an implantable material. 19.The surgical assembly of claim 18, wherein said implantable materialincludes a sheath situated about the implantable synthetic material. 20.The surgical assembly of claim 18, further comprising first and seconddilators to associate the first and second surgical instruments with theimplantable material.
 21. The surgical assembly of claim 16, wherein thehandle portion of the first surgical instrument includes indiciaindicating the first surgical instrument is for use on the right side ofthe patient, and wherein the handle portion of the second surgicalinstrument includes indicia indicating the second surgical instrument isfor use on the left side of the patient.
 22. The surgical instrument ofclaim 16 wherein the needle portion of the first instrument comprises afirst portion comprising comprises a curve having an arclength in threedimensions, and the needle portion of the second instrument comprises afirst portion comprising comprises a curve having an arclength in threedimensions.
 23. The surgical instrument of claim 22 wherein the needleportion of the first instrument comprises a first portion comprisingcomprises a helical curve, and the needle portion of the secondinstrument comprises a first portion comprising comprises a helicalcurve.
 24. A surgical instrument for treating a pelvic disorder,comprising: a needle sized and shaped to either: (a) initially extendthrough an incision substantially adjacent an obturator foramen of apatient and then through the obturator foramen along a path in a regionbetween the superior pubic ramus and the inferior pubic ramus to anincision in a position below the patient's urethra; or (b) initiallyfrom an incision in a position below a patient's urethra extendingthrough a region between the superior pubic ramus and the inferior pubicramus and then through an incision substantially adjacent an obturatorforamen of a patient.
 25. The surgical instrument of claim 24, whereinthe needle includes a pair of ends and wherein each of said pair of endshas a surface to associate with either an implantable material or aremovable handle.
 26. The surgical instrument of claim 24, wherein theneedle is sized and shaped for use on either the patient's right side orleft side.
 27. A surgical instrument for treating a pelvic disorder, theinstrument comprising: first and second ends, the instrument having aportion that is sized and shaped to extend from an incisionsubstantially adjacent an obturator foramen of a patient through theobturator foramen along a path in a region between the superior pubicramus and the inferior pubic ramus to an incision below the patient'surethra; one of the ends having a handle, at least the other end havinga securement surface to secure the instrument to another surgicalcomponent used to treat the pelvic disorder, wherein the securementsurface provides a secure attachment between the instrument and theother surgical component, in combination with the other surgicalcomponent, wherein the other surgical component comprises a dilator of asling assembly configured to treat a pelvic disorder.
 28. The instrumentof claim 27, wherein the instrument and the dilator have complementaryengagement surfaces to resist separation of the instrument from thedilator upon being snap fit together.
 29. The surgical instrument ofclaim 27 wherein the portion comprises a curve comprising an arclengthin three dimensions.
 30. The surgical instrument of claim 29 wherein theportion comprises a helical curve.